Methods and apparatus for atrioventricular valve repair

ABSTRACT

Methods and devices are disclosed for minimally invasive procedures in the heart. In one application, a catheter is advanced from the left atrium through the mitral valve and along the left ventricular outflow tract to orient and stabilize the catheter and enable a procedure such as a “bow tie” repair of the mitral valve. Right heart procedures are also disclosed.

This application is a continuation of U.S. application Ser. No.10/628,880, filed Jul. 28, 2003, which claims the benefit of U.S.Provisional Application No. 60/400,840, filed Aug. 2, 2002. Thedisclosure of each of the priority applications is hereby incorporatedby reference in its entirety herein.

FIELD OF THE INVENTION

The present invention relates generally to the field of heart valverepair. In a preferred embodiment, the invention relates to heart valverepair for patients suffering from mitral and/or triscupid valveregurgitation. It is a method and apparatus for repairing a cardiacatrioventricular valve consisting of a catheter(s)/guidance system thatuses the position of a leaflet immobilization device in the ventricularoutflow tract as a means of orientation so that immobilization of theleaflets will occur without interfering with the papillary muscles,chordal structures, or other cardiac structures. The method andapparatus provides a means for manipulating a catheter/apparatus toindependently capture and immobilize the leaflets of the heart at theoptimal central location, and a means for fastening these immobilizedleaflets together to accomplish a “bow-tie” repair.

BACKGROUND OF THE INVENTION

A major type of heart disease is valvular insufficiency, also calledvalvular regurgitation, which is characterized by the improper closingof a heart valve. A heart valve consists of a number of leaflets—eithertwo or three—that swing open to allow blood to flow forward(anterograde) out of a heart chamber, and then swing closed to form atight seal, preventing blood from leaking backwards (retrograde).Valvular insufficiency may result from a variety of problems with thecomponents which make up the valve—for example, the leaflets themselvesmay degenerate, the tissue cords which tether the leaflets to muscleswithin the heart may break, or the ring of tissue within which the valveis seated (called the “annulus”) may expand after heart attacks or fromcongestive heart failure. Each of these problems leads to a commonelement in valvular regurgitation: when closed, the edges of the valveleaflets no longer fit snuggly next to each other and allow retrogradeflow.

Mitral regurgitation (MR) (insufficiency of the valve which connects theleft atrium with the left ventricle of the heart) and tricuspidregurgitation (insufficiency of the valve which connects the rightatrium with the right ventricle of the heart) contribute significantlyto cardiovascular morbidity and mortality. MR is a debilitating diseasethat can lead to serious complications and possible death. Its symptomsinclude shortness of breath, rapid respirations, palpitations, chestpain, and coughing. MR also leads to infective endocarditis, heartfailure, pulmonary edema, stroke, arterial embolus, and arrhythmias,including atrial fibrillation and lethal ventricular arrhythmias.Detection and prompt effective treatment of MR leads to higher survivalrates, decreased complications, and increased comfort for patients.

Currently, the only method of definitively repairing valvularregurgitation is open-heart surgery: In this procedure, the patient isfirst anesthetized and then subject to a thoracotomy. Access to thepatient's heart is achieved by making a large incision, retracting theskin, muscle, and bony structures. The surgeon must stop the beating ofthe heart and cut it open to directly visualize the valve. The surgeonthen may repair the valve surgically, or remove the valve and implant aprosthetic valve replacement. This requires placing the patient oncardiopulmonary bypass, which is a machine that circulates oxygenatedblood throughout the body in place of the working heart and lungs.

Although open-heart surgery is a successful method of repairing orreplacing faulty heart valves, it poses a significant risk to the wellbeing of the patient, including death, severe injury, and disability.There is a risk of ischemic or other damage to the heart and other vitalorgans resulting from the discontinuance of the heart's normal function.The heart-lung machine may also cause abnormalities of the patient'scirculatory, respiratory, hematologic and neurologic systems. There is arisk of stroke and other consequences from emboli released into theblood during the surgery and during initiation of cardiopulmonarybypass. There is a risk of heart attack. Significant damage occurs tothe tissues and bone retracted from the patient's chest while gainingaccess to the heart. Post-operative complications such as woundinfection, pneumonia, and venous thrombosis occur because of the extentof incisions and the patient's debilitated state. Consequently, apatient's recovery can be painful, discomforting, long in duration, andcostly.

A minimally invasive, beating-heart procedure that would not expose thepatient to these risks is therefore desirable. Moreover, a limitedsurgical approach or percutaneous approach would decrease or eliminatethe tissue trauma that occurs from the extensive incisions of open-heartsurgery, sparing patients pain, improving recovery time, and decreasingpost-operative complications.

A very large population exists that would benefit from an alternativemethod of valve repair. Approximately 10% of coronary artery bypasssurgeries include mitral valve repair or replacement, which amounts to75,000 to 100,000 of such procedures per year world-wide. In addition,significant MR and/or TR complicate 30-60% of patients with congestiveheart failure, contributing to their impaired cardiac function andcausing significant morbidity. However, because of the significant risksinvolved in open-heart surgery, many of the patients are unable toundergo valve repair. Thus, a successful percutaneous orminimally-invasive method of valve repair on the beating heart wouldhave extraordinary clinical benefit.

No one, however, has successfully repaired the mitral valve of the humanheart with a minimally invasive, beating-heart procedure. Severalfactors are responsible for this. First, the heart and its associatedvalves are not directly visualized or accessible. One can use imagingtechniques such as fluoroscopy or echocardiography, but these provide atwo-dimensional image and a limited field of view. Second, it isextremely difficult to immobilize the rapidly moving heart valveleaflets for repair purposes while the heart is beating. Not only arethe leaflets moving back and forth rapidly, but also they each have adifferent shape and geometry, Thus, no single device or methodology hassuccessfully been used to repair heart valves in a minimally invasivemanner on a beating heart.

One method of surgical repair of the mitral valve, called the “bow-tie”repair (also referred to as the “edge-to-edge” repair), especially lendsitself to a percutaneous or minimally-invasive approach. In thistechnique, the patient is placed on cardiopulmonary bypass, the heart isstopped and incised to expose the mitral valve apparatus, and a singleedge-to-edge suture is placed through the edges of the valve leaflets,thereby apposing the anterior and posterior leaflets and resulting in a“double-orifice” valve. This surgical technique has led to satisfactoryreduction of mitral regurgitation (MR) with few re-operations andexcellent hemodynamic results. A successful minimally-invasive orpercutaneous device and method that would allow for the placement ofsuch a suture or another apposing element by remotely manipulating afastening device through the moving valve leaflets of the beating heartin a reliable and predictable manner would be a medical breakthrough.

There are several obstacles that such a device must overcome. Each valveleaflet moves independently, swinging open and closed as many as 40 to120 times a minute (or 1 to 2 times a second). Blood is surging back andforth through the valve at velocities often greater than 3 meters persecond. Each valve leaflet has a different shape, for example, theanterior leaflet of the mitral valve is long and relatively narrow,while the posterior leaflet is shallow and wide. The valve apparatus onthe ventricular side of the valve—consisting of primary, secondary, andtertiary chordae tendinae and the papillary muscles—makes themanipulation of devices in this area difficult, and consequently thesuccessful deployment of the device requires correctly negotiating thepathway through the valve without becoming entrapped within the cardiacstructures and/or damaging them. The suture or “fastener” mustincorporate enough leaflet tissue to prevent leaflet tearing and secureleaflet capture at the optimal location.

A number of patents describe devices and methods for placing a suturewithin tissue at a distance. U.S. Pat. No. 6,206,893 details a deviceand method for suturing of internal puncture sites, and U.S. Pat. No.6,117,145 provides a method and device for providing hemostasis atvascular penetration sites. These patents describe devices and methodsfor stitching a suture through a punctured blood vessel from a remotesite that is not under direct visual observation and thereby apposingthe edges of the blood vessel wall. These described methods and devicesare insufficient for properly and optimally capturing and fasteningcardiac valve leaflets, because they do not describe methods orapparatuses that are sufficient to ensure the proper alignment withintracardiac structures, the independent immobilization of the mobilevalve leaflets, and the fastening of tissues with specific leafletgeometry.

A number of patents address minimally invasive or percutaneous mitraland tricuspid valve repair, utilizing a variation of the concept of a“suture at a distance” derived from the open-heart “bow-tie” technique.U.S. Pat. No. 6,165,183 describes an approach to valve repair involvingthe performance of an edge-to-edge fastening of opposing heart valveleaflets through a catheter entering the heart. This patent describes acatheter to place a clip button on the two leaflets, and describesvarious embodiments of ways a clip can fasten two pieces of tissuetogether at a distance. No attention is paid however to the requirementsof placing the clip within a cardiac valve of a living patient,specifically, how moving valves can be grasped and immobilized; how thedevice is oriented with regard to the asymmetric leaflets and othercardiac structures so that a proper clip position is obtained; and aremedy for improper clip position. Thus, U.S. Pat. No. 6,165,183 doesnot describe a clinically feasible device or method for cardiac valverepair. U.S. Pat. No. 6,269,819 describes “an apparatus for the repairof a cardiovascular valve having leaflets comprising a grasper capableof grabbing and coapting the leaflets of the valve.” It is based on theconcept of a “bow-tie” repair performed at a distance. There is nodescription of a methodology of placing the device across the valve andavoiding cardiac structures. There is no description of how thegrasper—which essentially pinches the two leaflets together—cansimultaneously catch the two independently, rapidly moving leaflets in areliable fashion or at the optimal location, other than on the stoppedheart with the patient on cardiopulmonary bypass. As such, U.S. Pat. No.6,269,819 does not provide a clinically feasible or optimal approach tominimally invasive valve repair.

SUMMARY OF THE INVENTION

Disclosed herein is a method and apparatus for performing valve repairon a beating heart in a minimally invasive or percutaneous manner byintroducing at a distance a suture tie or fastener that will appose theleaflet edges and create a double-orifice valve. Importantly, the methodand apparatus uniquely provide for proper orientation within the heartto approach the asymmetric atrioventricular valve leaflets, enable theindependent capture of the moving leaflets, and provide for the releaseand re-securing of the leaflets if the initial position or fixation isnot optimal. The apparatus and methods described are optimized formitral valve repair, but it would be apparent to one skilled in the art,such as interventional cardiologists and cardiothoracic surgeons, thatminor changes in the device or techniques will also optimize theprocedure for tricuspid valve repair as well.

The apparatus consists of a catheter-based system for percutaneousadvancement and placement within the human heart consisting ofheart-valve leaflet immobilization and fixation devices housed withinone or more catheters. In a preferred embodiment, the device/apparatusconsists of (a) an orientation catheter which contains a central lumenfor a guide wire (b) one or more guide wires (c) a device HousingCatheter (HC) and (d) a Valve Immobilization Catheter (VIC) whichcontains the Leaflet Immobilization Apparatus. In alternativeembodiments of the device, the orientation catheter, device housingcatheter, and valvular immobilization catheter may be incorporated intoone or more catheters that may contain central lumens for guide wires.

The catheters each have a proximal end and a distal end. They maycontain a central lumen that is designed for placement over a guide wireand they may be torqueable and flexible as required for theiradvancement via the left atrium across the mitral valve, through theleft ventricular outflow tract, and across the aortic valve, where theproximal end may then sit in the ascending aorta. The route of thecatheter thereby provides a means of predictable orientation of thecatheter with respect to the papillary muscles, the anterior leaflet,and the posterior leaflet of the mitral valve. The shape of the catheterthus formed acts as a fulcrum about which the catheter can be easilymanipulated with respect to the individual valve leaflets.

The orientation catheter has an inflatable balloon at its distal end anda central lumen for a guide wire, and is advanced into the ascendingaorta from the left atrium. The placement of the catheter allows for theeasy advancement of the other elements of the device through the mitralvalve orifice, its chordal attachments, and the papillary muscleswithout getting entangled in these structures. A guide wire may beadvanced through the orientation catheter, allowing other catheters ofthe system (such as the Housing Catheter) to be exchanged over this wireso that the position of the distal aspect of the device in the ascendingaorta is maintained.

The Housing Catheter (HC) contains a central lumen through which theValve Immobilization Catheter (VIC) can be advanced. The HC contains twoports within proximity to the valve leaflets when the device is properlypositioned within the heart. These ports are openings that allow for thedeployment of leaflet immobilization supports and fixation devices thatsecure the valve leaflets. These supports and fixation devices arecontained within the Valve Immobilization Catheter that is advancedwithin the Housing Catheter.

The Valve Immobilization Catheter has a semi-rigid portion that containsthe leaflet immobilization apparatus. The leaflet immobilizationapparatus contains two asymmetric leaflet immobilization supports, oneoptimized for the anterior leaflet and one optimized for the posteriorleaflet with respect to size, angulation, and positioning along thelength of the catheter system. The leaflet immobilization apparatus alsocontains two fixating members that allow for the independent securing ofthe individual leaflets.

The method of device operation involves introducing the catheterapparatus into the left atrium through a sheath placed percutaneouslythrough the right femoral vein in the conventional transseptal cardiaccatheterization approach. A guide wire is manipulated through the sheathacross the mitral valve, through the left ventricular outflow tract(LVOT), and into the ascending aorta. The positioning of the guide wiremay be aided by first using a balloon floatation catheter (the“orientation catheter”) to cross the mitral valve and enter theascending aorta. The Housing Catheter and, within this, the VIC areadvanced over the wire into the ascending aorta. Now, given theanatomical fact that the anterior leaflet of the mitral valve also formsthe left ventricular outflow tract, the catheter position has provided aspecific orientation with respect to the asymmetric valve leaflets,automatically aligning the device between the chordal attachments to thepapillary muscles. The operator then engages the valve leaflets byremotely actuating the deployment of the anterior leaflet immobilizationsupport (LIS) and then does the same with the posterior LIS. Once theproper alignment of both is confirmed by fluoroscopic and/ortransthoracic, transesophageal, or intracardiac echocardiographicvisualization, the leaflets are fastened together by fixating materialupon further remote actuation by the operator. The adequacy of therepair is assessed by fluoroscopy and/or echocardiography and thefastening is revised if needed. One then pulls the fastening materialtight, withdraws the catheter system, and ties the fastening material,thereby apposing the edges of the valve leaflets and completing thevalve repair.

In alternative embodiments, the orientation catheter, Housing Catheter,Valve Immobilization Catheter, and Leaflet Immobilization Apparatus maybe incorporated into one or more catheters, each of which may or may notcontain an inflatable balloon at its distal end.

In alternative embodiments, the catheters of the system may contain apre-shaped curve to assist in advancing them through the left ventricleinto the aorta.

In another embodiment, the sheath may be placed across the interatrialseptum, through the left ventricle, and into the aortic root, and thenthe sheath is withdrawn exposing the immobilization and fixationcomponents of the device.

In another embodiment, the fixating members may deploy a crimp or stapleto appose the leaflet edges in an edge-to-edge repair.

In another method aspect, the device may be introduced into the leftatrium through an incision the the left atrium or through a directpuncture of a pulmonary vein; or through an incision into the rightatrium and then into the left atrium through a trans-septal puncture; orpercutaneously through an internal jugular vein and across theinter-atrial septum; or through a femoral vein and across theinter-atrial septum; or any other central venous access that provides aroute to the right atrium and then across the inter-atrial septum.Modifications to the device/apparatus such as the orientation of theleaflet immobilization supports would allow introduction through aperipheral artery and retrograde from the aorta into the left ventricleand then the left atrium.

In another method aspect, magnetic resonance imaging, fluoroscopy, anddifferent forms of echocardiography, including transesophagealechocardiography including transesophageal echocardiography,transthoracic echocardiography, intracardiac echocardiography, andthree-dimensional cardiography may assist with device position andadvancement within the heart and body, leaflet immobilization, and thedetermination if the leaflet apposition achieved by the device isadequate.

In another method aspect, the device may be used for tricuspid valverepair, by gaining access to the right atrium through a direct incisionor through a percutaneous route and by advancing the device through theright ventricular outflow tract and into the pulmonary artery toestablish proper orientation with respect to the individual tricuspidvalve leaflets.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a photograph of a pathologic specimen of a human heartsectioned along its long axis, demonstrating the pertinent anatomicalstructures and landmarks important to device operation.

FIG. 2 is a photograph of a pathologic specimen of a human heart,sectioned in short axis at the level of the left atrium, demonstratingthe anatomy of the mitral valve leaflets as viewed from the perspectiveof the left atrium and the approach of the invention.

FIG. 3 is a schematic representation of a human heart and one embodimentof the present invention showing the position within the heart and bloodvessels that provides correct orientation.

FIG. 4 is a side view of one embodiment of the present invention showingthe device positioned between the two heart valve leaflets prior toleaflet immobilization support deployment.

FIG. 5 is a side view of one embodiment of the present invention showingthe anterior leaflet immobilization support partially extended from ananterior portal and positioned below the anterior leaflet.

FIG. 6 is a side view of one embodiment of the present invention showingthe anterior leaflet immobilization support fully extended and engagingthe anterior leaflet.

FIG. 7 is a side view of one embodiment of the present invention showingthe anterior leaflet immobilization support fully extended and incontact with an anterior heart valve leaflet, and the posterior leafletimmobilization support partially extended from a posterior portal andpositioned below the posterior leaflet.

FIG. 8 is a side view of one embodiment of the present invention showingthe anterior leaflet immobilization support fully extended and engagingthe anterior heart valve leaflet, and the posterior immobilizationsupport fully extended and engaging the posterior leaflet.

FIG. 9 is a side view of one embodiment of the present invention showingthe leaflet immobilization supports engaging the anterior and posteriorleaflets with the fixation devices deployed and securing the anteriorand a posterior leaflets.

FIG. 10 is a side view of one embodiment of the present inventionshowing the fully extended leaflet immobilization supports disengagingthe anterior and posterior leaflets, and fastening material drawnthrough the these leaflets.

FIG. 11 is a side view of one embodiment of the present invention theanterior leaflet immobilization support extended, the posterior leafletimmobilization support fully withdrawn, and fastening material drawnthrough the anterior and posterior leaflets.

FIG. 12 is a side view of one embodiment of the present inventionshowing the leaflet immobilization supports completely withdrawn, andfastening material drawn through the anterior and posterior leaflets.

FIG. 13 is a side view of one embodiment of the present inventionshowing fastening material drawn through the anterior and posteriorvalve leaflets, with the leaflet immobilization apparatus and itshousing catheter withdrawn over a guide wire.

FIG. 14 Shows tying of suture.

FIG. 15 is a side view of the coapted anterior and posterior heartleaflets secured together by a fastening material resulting inedge-to-edge apposition, also referred to as a “bow-tie” repair.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

In FIG. 1, a longitudinal section of the human heart is showndemonstrating the left atrium 1, the mitral valve orifice 2, theanterior leaflet of the mitral valve 3, and the posterior leaflet of themitral valve 4. The subvalvular apparatus consists of the numerouschordae tendinae 5 and the papillary muscles 6. The left ventricularoutflow tract (LVOT) 10 is a channel formed by the anterior leaflet ofthe mitral valve 3 and the interventricular septum. This Figuredemonstrates the pathway the distal end of the device must take from theleft atrium 1, through the mitral valve orifice 2, between the papillarymuscles 6, through the LVOT 10, across the aortic valve 8 and into theascending aorta 9.

In FIG. 2, a short axis view of the mitral valve is seen at the level ofthe left atrium. This demonstrates the asymmetric nature of the mitralvalve leaflets. The posterior leaflet 4 has a broad base and of narrowwidth, while the anterior leaflet 3 has a relatively narrow base and asubstantial width.

One embodiment of the orientation catheter 11 in relation to these heartstructures is depicted schematically in FIG. 3. The distal end 11 of thecatheter is the one advanced through the body; the proximal end 13 isthe end closest to the operator. In subsequent Figure, the proximal endis illustrated at the left portion of the Figure, and the distal end atthe right, unless stated otherwise. A sheath 12 is placed through acentral venous access and advanced through the inferior venae cavae 14,into the right atrium 15, and trans-septally into the left atrium 1using the conventional cardiac catheterization technique. The catheter11 is advanced through the sheath into the left atrium 1, between theanterior 3 and posterior 4 leaflets, into the LVOT 10, and through theaortic valve 8 into the ascending aorta 9. This position through theLVOT 10 orients the catheter with respect to the anterior mitral valveleaflet 3 and the posterior leaflet 4.

The preferred embodiment shown in FIG. 3 employs an inflatable balloonto assist the operator in placing a guide wire from the left atrium toascending aorta. The length of the catheter 11 is sufficient for thelength of the approach from the insertion site to the ascending aorta.Balloon and catheter constructions are well known in the art. U.S. Pat.No. 6,051,014 (“the '014 patent”), the contents of which areincorporated by reference in their entirety herein, discloses variousballoon-tipped catheter construction. All of the foregoing rangesillustrate typical and preferred dimensions only; one could employ acatheter that is greater or shorter in any of these dimensions. What isimportant is that the catheter has the dimensions that permit one toinsert it via the desired route. The catheter illustrated in FIG. 3, forexample, has the dimensions that make it appropriate for percutaneousplacement through central venous access such as the right femoral vein.

The inflated balloon 16 at the distal end of the catheter 11 is filledwith a gaseous substance such as air, or CO₂. The gaseous substancegives buoyancy to the inflated balloon 16 and permits floatation inliquid substances such as blood. With the distal end of the catheter 11attached to the inflated balloon 16 the flow of blood naturally carriesthe catheter 11 through the valve leaflets 3,4; around and into the LVOT10, and up through the aortic valve 8 into the ascending aorta 9. In analternative embodiment, the entire device may be incorporated into oneor more balloon-tipped catheters.

Once the orientation catheter 11 is in place, a guide wire 17 may thenbe advanced through the lumen of the catheter 11, the guide wire actingas a path to withdraw or advance catheters or apparatuses easily to theascending aorta 9. In another embodiment, one could advance thiscatheter with or without a balloon tip over a guide wire into itsposition in the aortic root using techniques known to those skilled inthe art. At this point, the catheter 11 may be withdrawn and the guidewire 17 left in place. Alternatively, the catheter 11 and the guide wire17 may both be left in their same position. In either case, theorientation catheter 11 and/or the guide wire 17 may serve as a path toadvance and place the device Housing Catheter 18 and the ValveImmobilization Catheter (VIC) 19.

The following embodiments generally refer to FIGS. 4 through 15. In oneembodiment, the orientation catheter once in place in the ascendingaorta may be removed over a guide wire and the device Housing Catheter18 advanced over the wire until its distal end is in the ascendingaorta. The device Housing Catheter 18, like the orientation catheter 11,is made of material flexible and torqueable, preferably of a polymericmaterial but any other biocompatible material may be used. The deviceHousing Catheter 18 contains a central lumen through which the valveimmobilization catheter (VIC) 19 can be advanced, and has in its wallholes 20, 21 (herein referred to as “portals”) that, once the HousingCatheter 18 is in place in the ascending aorta with the assistance ofthe orientation catheter, are specifically aligned with the locations ofthe anterior 3 and posterior 4 leaflets to allow for the deployment ofleaflet immobilization supports (LISs) 22, 23 incorporated into the VIC19 that unfold and project out of the apparatus to immobilize theindividual leaflets. The Housing Catheter 18 also contains holes withinits walls for the extension of fixation devices 24 and 25 from the VIC19. The VIC 19 is a catheter with a central lumen for a guide wire, ismade of material flexible and torqueable, and has a semi-rigid portionthat contains the leaflet immobilization apparatus, which consists ofthe leaflet immobilization supports 22, 23, the spring hinge 26, and thefixation devices 24, 25. In an alternative embodiment, the fixationdevices 24, 25 may be incorporated into another element of the cathetersystem such as the Housing Catheter 18, or in a separate portion of theVIC 19 at a distance from the other parts of the leaflet immobilizationapparatus. In an alternative embodiment, the device Housing Catheter 18and VIC 19 may be incorporated into a single catheter with a movablecore and may contain a central lumen for a guide wire.

Monitoring the advancement and manipulation of the orientation catheter11, the guide wire 17, the device Housing Catheter 18, and the VIC 19may be done by a variety of visualization techniques including, but notlimited to MRI, fluoroscopy, endoscopy, thoracoscopy, transthoracic,intracardiac, and transesophageal echocardiography. These and othervisualization techniques are employed throughout the present inventionto track the movement of the apparatus inside a human body.

FIG. 4 depicts in longitudinal section one embodiment of the presentinvention for mitral heart valve repair showing a Housing Catheter 18,advanced through a sheath 12 placed as depicted in FIG. 3, over a guidewire and into the proper position between the mitral valve leaflets 3and 4. The VIC 19 with its incorporated leaflet immobilization apparatusconsisting of the leaflet immobilization supports 22, 23, and springhinge 26 has been advanced over a guide wire through the device HousingCatheter 18 and into proper position with respect to the mitral valveleaflets 3 and 4. Through advancement, retraction, and torquing of theVIC 19 by the operator, the VIC allows the operator to manipulate theincorporated leaflet immobilization apparatus. The function of theleaflet immobilization apparatus (consisting of the leafletimmobilization supports 22, 23, spring hinge 26, and fixation devices24, 25) is to isolate, immobilize, and fixate the individual valveleaflets. These components of the leaflet immobilization apparatus arepreferably made of a sterile, biocompatible material such as metal orplastic. The leaflet immobilization apparatus is preferably cylindricalin shape, but may also be rectangular, conical or a multitude of othershapes. The leaflet immobilization apparatus comprises two leafletimmobilization supports (“LIS”)—one anterior 22 and one posterior 23connected to a spring hinge 26 incorporated into the VIC 19. In mitralheart valve repair, the anterior LIS 22 may be longer than the posteriorLIS 23, thus taking into account the anatomical difference in the sizeand shape of an anterior mitral valve leaflet 3 compared to a posteriormitral valve leaflet 4 as demonstrated in FIG. 2. By way of example, theshape of the LIS 22, 23 may resemble thin rectangular arms or wings thatare connected by a hinge 26. However, the design of the LIS 22, 23 maybe shaped in a variety of different forms. For example, the LIS 22, 23may be circular, triangular, square, oval, or elliptical. The LIS 22, 23may also be straight or curved. Differences in the sizes of the LIS 22and 23 may be tailored to the anatomical requirements of a particularsurgical repair and patient. In any case, the shape of the LIS 22, 23are designed to fit within the lumen of a catheter and, when deployed,to optimally interface with the unique anatomical shape of the anteriorleaflet 3 and posterior leaflet 4, respectively. In addition, the hingeconnecting the LIS 22, 23 may also comprise a spring 26. When the LIS22, 23 are located outside the lumen of the catheter, the spring hinge26 connecting the LIS 22, 23 extends the LIS 22, 23 outward and awayfrom catheter system. The spring hinge 26 limits the range of movementof the LIS 22, 23 from a closed position, or zero degrees, to an openposition not to exceed 90 degrees away from the catheter system. Thespring 26 exerts relatively little force against the LIS 22, 23 in theopen position. When the LIS 22, 23 is contained within the lumen of theHousing Catheter 18, the walls of the lumen force the LIS 22, 23 inward.In an alternative embodiment, the closed position of LIS 22, 23 may bemaintained by a latch mechanism that can be released by an actuator inthe proximal portion of the VIC 19. Thus, in the lumen of the housingcatheter, the LIS 22, 23 are flush within the Housing Catheter 18, andthe spring hinge 26 is loaded with the force of the LIS 22, 23 in aclosed position. To ease advancement of the VIC with its incorporatedleaflet immobilization apparatus, the Housing Catheter 18 may containgrooves shaped to receive the LIS 22, 23, or to receive the VIC 19 in aproper orientation so that LIS 22, 23 are directed properly toward theexit ports 20, 21 in the Housing Catheter 18. In an alternativeembodiment, the Housing Catheter 18 and the VIC 19 with its incorporatedleaflet immobilization apparatus may be incorporated into a singlecatheter with a moveable core that allows for the manipulation of theLIS 22,23, the spring hinge 26, and fixation devices 24, 25 by actuatoror actuators at the proximal end of the catheter system, or by directmanipulation of the core itself at the proximal end of the cathetersystem.

FIG. 4 thus depicts the VIC 19 advanced within the Housing Catheter 18and the LIS 22, 23 in closed positions. The VIC 19 has been advancedwithin the Housing Catheter 18 so that the LIS 22, 23 are positionedbelow the ventricular aspect of the open anterior 3 and posterior 4leaflets. The LIS 22, 23 are now ready for deployment.

FIGS. 4, 5 and 6 sequentially depict one embodiment of the presentinvention's independent deployment of anterior LIS 22. In FIG. 4 the VIC19 is shown advanced toward the distal end of the housing catheter 18that has an anterior portal 20. The proximal end of VIC 19 may extendoutside the proximal end of the housing catheter 18. This enables theoperator to push and pull the VIC 19 in a distal or proximal directionwithin the catheter. As the operator pulls it in the proximal direction,the leaflet immobilization apparatus (consisting of the LIS 22,23, andthe hinge 26) moves in a proximal direction within the Housing Catheter18. In addition, gradually, the anterior LIS 22 independently extendsoutward from the anterior portal 20 as the entire length of the anteriorLIS 22 moves proximally toward the open space of the Housing Catheter's18 anterior portal 20. The anterior LIS 22 independently extends outwardfirst because of the differential lengths of anterior LIS 22 andposterior LIS 23 and because of the differential locations of theanterior portal 20 and the posterior portal 21. Without the containmentof the lumen walls of the Housing Catheter 18, the force of the loadedspring hinge 26 extends the anterior LIS 22 through the anterior portal20 of the Housing Catheter 18 away from the VIC 19. In an alternativeembodiment of the present invention, an operator may release theanterior LIS 22 or actuate the deployment of the anterior LIS 22 by wayof an actuator located at the proximal end of the VIC 19. Referring backto FIG. 1, the tips of the mitral valve leaflets 3 and 4 point in aventricular direction when open. Thus, the angle of the deployedanterior LIS 22 allows for the engagement of the ventricularly directedanterior valve leafet 3. Incorporating FIG. 1's frame of referenceregarding the mitral valve leaflets 3 and 4, FIG. 5 shows the anteriorLIS 22 free from the lumen of the housing catheter 23 and in a partiallyextended position below the anterior mitral valve leaflet 3. FIG. 6 nextshows the anterior LIS 22 in a fully extended position below theanterior leaflet 3, and engaging the anterior leaflet 3. Once theanterior LIS 22 is fully extended and positioned below the anteriorleaflet 3, the flexible and torqueable nature of the housing catheter 18and the VIC 19 allow the operator to move and adjust the housingcatheter/VIC system until he or she has determined that the anterior LIS22 is positioned optimally below the anterior leaflet 3, using imagingtechniques such as fluoroscopy, MRI, transesophageal, intracardiac,transthoracic, or three-dimensional echocardiography as needed.

FIGS. 7 and 8 sequentially depict one embodiment of the presentinvention showing the independent deployment of posterior LIS 23. Oncethe anterior LIS 22 extends through the anterior portal 20, the operatormay further pull VIC 19 in a proximal direction. This movement willcause the posterior LIS 23 to move from the lumen of the catheter to theopening of the posterior portal 21. The posterior LIS 23 may be shorterthan the anterior LIS 22 taking into account the size difference of theanterior 3 and posterior 4 mitral valve leaflets. Similar to theindependent deployment of anterior LIS 22, posterior LIS 23 graduallyand independently springs to an open position as the operator pulls theVIC 19 proximally. In an alternative embodiment of the presentinvention, an operator may actuate the release and/or deployment of theposterior LIS 23 by way of an actuator located at the proximal end ofthe VIC 19. In FIG. 7, the posterior LIS 23 is shown in a partiallyextended position shortly after clearing the lumen of the HousingCatheter 18 through the posterior portal 21. Similar to anterior LIS 22positioning, the posterior LIS 23 is positioned at the ventricular sideof posterior leaflet 4. In FIG. 8, posterior LIS 23 is in a fullydeployed position and is optimally positioned under posterior leaflet 4.Upon determining the optimal positioning of the LIS 22, 23 in relationto the anterior 3 and posterior 4 leaflets, fixation devices 24, 25 areused to immobilize the leaflets 3, 4 in one embodiment of the inventionas depicted in FIG. 9. The fixation devices 24, 25 are preferably curvedneedles, made of plastic or metal, that, upon manipulation by anoperator of an actuator at the proximal end of the device, extend fromthe proximal end of the VIC 19 in relation to the LIS 22, 23. However,other fixating devices and methods are contemplated as well.Importantly, the specific angles of the fixation devices extensions inrelation to LIS 22,23 allow for the fixation of the leaflets in theircentral portions, which prevents leaflet tearing and ensures the optimalamount of leaflet tissue is encaptured, improving the surgical result.If, using visual aids such as fluoroscopy, transesophageal,transthoracic, and/or intracardiac echocardiography, the operatordetermines that the leaflets 3, 4 are not in optimal apposition for asuccessful repair, the fixating devices 24, 25 may be withdrawn from theleaflets 3, 4 by actuation of the actuator; the leaflet immobilizationapparatus is repositioned in relation to the leaflets 3, 4; and thefixating devices 24, 25 are deployed again to pin the leaflets 3, 4. Thereadjustment of the Housing Catheter 18, the VIC 19, and its leafletimmobilization supports 22, 23 and fixation devices 24, 25 may berepeated until the optimal apposition of the leaflets 3, 4 is achieved.After an operator determines that both leaflets 3, 4 are pinned in anoptimal position the operator may lock the position of the fixationdevices 24, 25 through further actuation of the fixation devices 24, 25.

FIG. 9 also depicts one embodiment of the present invention in which afastening material is prepared to be drawn through the edges of theanterior 3 and posterior 4 mitral valve leaflets. In one embodiment ofthe present invention, anterior 22 and posterior 23 LIS may each hold alink 28, 29. Each link 28, 29 is connected to one end of a continuousfastener material 30. In an alternative embodiment of the presentinvention, each end of the fastener material 30 may be attached to someother needle capturing device. Each link 28, 29 receives the piercingpoint of the fixation devices 24, 25. Subsequent manipulation of anactuator on the proximal end of the catheter by the operator results inthe retraction of the fixating devices 24,25 as shown in FIG. 10. Thefixating devices 24, 25 return to their original position within HousingCatheter 18 and in the process pull the links 28, 29 and attachedfastening material 30 through the leaflets 3, 4. Further withdrawal ofthe fixating devices 24, 25 proximally by direct manipulation by theoperator of the proximal end of the device or by using an actuator atthe proximal end of the device results in the tightening of thefastening material 30 through the leaflets 3, 4.

In one embodiment of the present invention, after the fastening material30 is drawn through the anterior 3 and posterior 4 leaflets, theposterior LIS 23 independently retracts through the posterior portal 21to its original position flush within the Housing Catheter 18 as shownin FIG. 11. The independent retraction of the posterior LIS 23 may becaused by the distal advancement of the VIC 19 back to its originalstarting position prior to deployment, or by the manipulation by theoperator of an actuator at the proximal end of the device. The springhinge 26 gives flexibility to and allows for the posterior LIS 23 toreturn to its position flush within the housing catheter lumen. Furtherdistal advancement of the VIC 19 repeats the same retraction process forthe anterior LIS 22 as for the posterior LIS 23 as shown in FIG. 12. InFIG. 12, one embodiment of the present invention depicts both theanterior 22 and posterior 23 LIS in a closed position and advanced pasttheir respective portals 20, 21. In an alternative embodiment of thepresent invention, the operator may actuate an actuator on the proximalend of the device to independently retract the anterior 22 and posterior23 LIS, resulting in the same depiction as shown in FIG. 12.

In one embodiment of the present invention, the fastening material isreleased from the arms of LIS 22, 23, and the VIC 19 and the HousingCatheter 18 are then withdrawn together from between the anterior 3 andposterior 4 leaflets over the guide wire 17 as depicted in FIG. 13. Theends of the fastening material 30 are tied together and the knotadvanced to the leaflet tissue as shown in FIG. 14. In an alternativeembodiment of the present invention, a clip, crimp, or other materialmay be advanced to tie the fastening material 30 together. The tying ofsutures and fastening material is well known in the art and anyappropriate method may be employed. In another embodiment of the presentinvention, the fastening material 30 may act as a crimp, which, afterwithdrawal of the VIC 19 and Housing Catheter 18, is sealed and releasedremotely be the operator.

Upon completion of the bow-tie repair, the guide wire 17 is removed frombetween the leaflets 3, 4 as shown in FIG. 15.

Although certain specific methods and devices have been describedherein, the inventors contemplate the invention as more generallydirected to methods of orienting catheters in the heart, and performingprocedures within the heart, as well as more generally to catheters forenabling such procedures. For example, one aspect of the inventioncomprises a method of performing a procedure in the heart. The methodcomprises the steps of providing a catheter, having an elongate flexiblebody. The body comprises a proximal end, a distal end, and procedurezone, spaced proximally apart from the distal end. As will be apparentto those of skill in the art in view of the disclosure herein, theprocedure zone comprises a zone on the catheter where a procedure may beinitiated or accomplished. Thus, it may comprise an opening in the sidewall of the catheter, a distal opening on an outer sleeve whichterminates proximally to the distal end of the catheter, or a device orstructure carried by the catheter which is operable to initiate orconduct a therapeutic or diagnostic procedure.

The method additionally comprises the step of advancing the catheterantegrade, in one implementation of the invention, through the mitralvalve, through the aortic valve and into the aorta. This enables theprocedure zone to be positioned upstream from the aortic valve, andallows the distal end of the flexible body to serve as an anchor toanchor and stabilize the catheter within the heart. A procedure may thenbe performed or initiated from the procedure zone on the catheter. Thus,the procedure zone is spaced proximally of the distal end a sufficientamount to allow the distal end of the catheter to anchor in ananatomical region of the heart or surrounding vasculature, such as, inthis example, the left ventricular outflow tract.

The advancing step may comprise advancing the catheter along apreviously positioned guidewire. The method may additionally comprisethe step of allowing a flow directed catheter to flow through the mitralvalve, through the aortic valve, and into the aorta, and thereafteradvancing the guidewire through the flow directed catheter. The flowdirected catheter may be removed, leaving the guidewire in place.Alternatively, the device catheter or catheters may be advanced alongthe flow directed catheter, such as where the flow directed catheter isa flow directed guidewire, or functions as a flow directed guidewire.

The advancing step may comprise advancing the catheter to position theprocedure zone within a flow path between the mitral valve and theaortic valve.

The procedure may be a diagnostic procedure, or a therapeutic procedure.It may comprise an imaging procedure, or a hemodynamic monitoringprocedure. The procedure may alternatively comprise an ablationprocedure, recanalization procedure, drug delivery procedure, or any ofa variety of tissue manipulation procedures, including valve repairprocedures, such as an atrioventricular valve repair. For example, theprocedure may comprise the step of grasping at least one leaflet of themitral valve. The procedure may attach the anterior leaflet of themitral valve to the posterior leaflet of the mitral valve.

In accordance with another aspect of the present invention, there isprovided a method of orienting a first and second tissue grasper withrespect to the mitral valve. The method comprises the steps of providinga catheter, having an elongate, flexible body, with a proximal end, adistal end, and first and second tissue graspers spaced apart from thedistal end. The distal end of the catheter is transluminally advancedfrom the left atrium through the mitral valve and along the leftventricular outflow tract into the ascending aorta. The distal end ofthe catheter is positioned in the ascending aorta to stabilize andposition the first and second tissue graspers, such that they areadjacent the mitral valve.

The method next comprises the step of extending at least the firsttissue grasper radially outwardly from the flexible body. The extendingstep may comprise advancing the first tissue grasper from a firstposition in which a longitudinal axis of the tissue grasper extendsgenerally parallel with the flexible body, to a second position in whichthe axis is inclined with respect to the flexible body. Depending uponthe desired device construction, the axis of the tissue grasper may beinclined radially outwardly in a proximal direction, or radiallyoutwardly in a distal direction. Alternatively, the extending step maycomprise advancing the first tissue grasper distally along a pathwaywhich is inclined with respect to a longitudinal axis of the catheter.

In accordance with another aspect of the present invention, there isprovided a method of grasping a mitral valve leaflet. The methodcomprises the steps of providing a catheter having an elongate, flexiblebody, with a proximal end and a distal end. The distal end istransluminally advanced from the left atrium through the mitral valveand along the left ventricular outflow tract into the ascending aorta.In any of the procedures discussed herein, the catheter may enter theleft atrium through any of the known transvascular or surgical pathways.A tissue grasper may be then deployed from a position on the catheter,spaced apart from the distal end. A mitral valve leaflet is graspedusing the tissue grasper. Depending upon the tissue grasperconfiguration, the grasping step may comprise piercing the leaflet,trapping the leaflet, applying suction to the leaflet, or other tissuegrasping technique.

In accordance with another aspect of the present invention, there isprovided a method of performing an atrioventricular valve repair. Themethod comprises the steps of providing a catheter having an elongateflexible body, with a proximal end, a distal end, and at least oneleaflet grasper thereon. The distal end is transluminally advanced fromthe left atrium, through the mitral valve and along the left ventricularoutflow tract into the ascending aorta. At least a first leaflet of themitral valve is grasped with the leaflet grasper, and the first leafletis secured to at least one other anatomical structure. In oneimplementation of the invention, the first leaflet is secured to asecond leaflet. Alternatively, the first leaflet may be secured to avalve annulus. The securing step may comprise advancing a suture throughthe first leaflet. Alternatively, the securing step may compriseattaching a clip to the first leaflet. The securing step mayalternatively comprise attaching a tissue anchor to the first leaflet.

In accordance with a further aspect of the present invention, there isprovided a method of orienting a catheter with respect to the mitralvalve. The method comprises the steps of positioning a guidewire fromthe left atrium through the mitral valve and along the left ventricularoutflow tract into the ascending aorta. A catheter is advanced along theguidewire, the catheter having an anchor and a procedure site. Theanchor is located with respect to an anatomical feature, such that theprocedure site is at a predetermined orientation with respect to themitral valve. The positioning step may include the use of a flowdirected structure. The locating the anchor step may comprisepositioning a distal portion of the catheter within the ascending aorta.The locating the anchor step may comprise positioning the catheter suchthat it is approximately centered on the posterior leaflet of the mitralvalve.

The methods and devices of the present invention may be configured toaccess either the right side or the left side of the heart. In general,a right side procedure involves advancing the catheter from the rightatrium through the right ventricle and into the pulmonary artery. Thecatheter is anchored in the pulmonary artery, along the right ventricleoutflow tract. Right side positioning enables procedures to be performedon the tricuspid or pulmonic valve, as will be apparent to those ofskill in the art in view of the disclosure herein, utilizing proceduresand devices disclosed elsewhere herein, except that the right sideprocedures will not require a transseptal crossing. Access for any ofthe procedures described herein could be by way of a puncture in theleft ventricle, left atrium, aorta, or right atrium for off pump valverepair in an open surgery.

Thus, in accordance with another aspect of the present invention, thereis provided a method of performing a procedure in the heart. The methodcomprises the steps of providing a catheter having an elongate flexiblebody, a proximal end, a distal end, and a procedure zone spacedproximally apart from the distal end. The catheter is advanced throughthe right atrium, through the right ventricle, and into the pulmonaryartery, such that the procedure zone is positioned at a treatment site.A procedure may thereafter be performed from the procedure zone. In oneapplication of the invention, the procedure is performed on thetricuspid valve. Alternatively, the procedure may be performed on thepulmonic valve. The advancing step may comprise advancing the catheterto a position such that the distal end of the catheter is within theright ventricle outflow tract of the pulmonary artery.

In accordance with another aspect of the present invention, there isprovided a method of performing a procedure in the heart. The methodcomprises the steps of providing a catheter, having an elongate flexiblebody, a proximal end, a distal end, and a procedure zone spacedproximally apart from the distal end. The catheter is advanced throughat least two valves in the heart, through a first chamber in the heartand at least into and in some implementations through a second chamberin the heart. This enables positioning of the procedure zone adjacent orin the proximity of a desired treatment site. A procedure is thereafterperformed from the procedure zone. In one application of the invention,the advancing the catheter step comprises advancing the catheter throughboth the mitral valve and the aortic valve. The procedure may comprise avalve repair.

As discussed previously herein, the present invention also provides avariety of catheters, for performing the procedures disclosed herein. Inaccordance with one aspect of the present invention, there is provided acatheter for accessing the heart. The catheter comprises an elongateflexible body, having a proximal end and a distal end. The distal endincludes an anchor zone. At least one tissue manipulator is carried bythe flexible body, proximally of the anchor zone.

In general, the anchor zone is of a sufficient length distally of theprocedure zone, to enable orientation and anchoring of the catheterwithin the vasculature. In one embodiment, the minimum length of theanchor zone is at least about 3 cm. In some embodiments, the anchor zoneis at least about 5 cm, and in certain applications, at least about 10cm in length.

The tissue manipulator may be movable between an axial orientation ortransluminal navigation and an inclined orientation for manipulatingtissue. In certain embodiments, the catheter may comprise a first and asecond tissue manipulator. The tissue manipulator may comprise a tissuegrasper for grasping a heart valve leaflet. In many embodiments, thecatheter comprises at least a first component which is axially movablewith respect to a second component, to manipulate tissue such as tograsp and secure opposing leaflets on a valve.

Although the present invention has been disclosed with reference tocertain specific embodiments of devices and methods, the inventorscontemplate that the invention more broadly relates to methods disclosedabove, such as those useful for orienting a catheter with respect to ananatomical structure, as well as performing diagnostic and/ortherapeutic procedures in the heart or adjacent the heart. Accordingly,the present invention is not intended to be limited to the specificstructures and steps disclosed herein, but rather by the full scope ofthe attached claims.

What is claimed is:
 1. A method of performing a procedure in the heart,comprising the steps of: providing a catheter having an elongateflexible body, a proximal end, a distal end, and a procedure zone,spaced proximally apart from the distal end; advancing the catheterantegrade through the mitral valve, through the aortic valve and intothe aorta, such that the procedure zone is positioned upstream from theaortic valve and a length of the catheter extending proximally of thedistal end is positioned in the ascending aorta, the length of thecatheter extending proximally of the distal end providing a fulcrum formanipulating the procedure zone by torqueing the proximal end, thelength of the catheter extending proximally of distal end having amaximum outer periphery smaller than the inner periphery of theascending aorta; and performing a procedure on the mitral valve from theprocedure zone while maintaining the maximum outer periphery of thelength of the catheter extending proximally of the distal end smallerthan the inner periphery of the ascending aorta to provide a flow pathfor blood ejected from the heart by contraction of the left ventriclearound the distal end of the catheter during the procedure.
 2. Themethod of performing a procedure in the heart as in claim 1, wherein theadvancing step comprises advancing the catheter along a guidewire. 3.The method of performing a procedure in the heart as in claim 2,additionally comprising the steps of positioning a flow directedcatheter through the mitral valve, through the aortic valve and into theaorta, advancing the guidewire through the flow directed catheter, andremoving the flow directed catheter.
 4. The method of performing aprocedure in the heart as in claim 2, wherein the guidewire is a flowdirected guidewire.
 5. The method of performing a procedure in the heartas in claim 2, wherein the catheter comprises an opening in a side wallof the catheter.
 6. The method of performing a procedure in the heart asin claim 2, wherein the catheter comprises an outer tubular wall havinga central lumen, and an inner elongate flexible body extendable throughthe central lumen, and the procedure zone comprises an opening at adistal end of the outer tubular wall.
 7. The method of performing aprocedure in the heart as in claim 1, wherein the catheter is a flowdirected catheter.
 8. The method of performing a procedure in the heartas in claim 1, wherein the advancing step comprises advancing thecatheter to position the procedure zone within a flow path between themitral valve and the aortic valve.
 9. The method of performing aprocedure in the heart as in claim 1, wherein the procedure zonecomprises an opening carried by the catheter.
 10. The method ofperforming a procedure in the heart as in claim 1, wherein the procedurecomprises a diagnostic procedure.
 11. The method of performing aprocedure in the heart as in claim 1, wherein the procedure comprises atherapeutic procedure.
 12. The method of performing a procedure in theheart as in claim 1, wherein the procedure comprises an imagingprocedure.
 13. The method of performing a procedure in the heart as inclaim 1, wherein the procedure comprises a hemodynamic monitoringprocedure.
 14. The method of performing a procedure in the heart as inclaim 1, wherein the procedure comprises an ablation procedure.
 15. Themethod of performing a procedure in the heart as in claim 1, wherein theprocedure comprises an atrioventricular valve repair.
 16. The method ofperforming a procedure in the heart as in claim 1, further comprisingthe step of transluminally advancing the catheter through the intraatrial septum prior to the advancing step.
 17. The method of performinga procedure in the heart as in claim 1, wherein the procedure comprisesgrasping at least one leaflet of the mitral valve.
 18. The method ofperforming a procedure in the heart as in claim 1, wherein the procedurecomprises attaching the anterior leaflet of the mitral valve to theposterior leaflet of the mitral valve.
 19. The method of performing aprocedure in the heart as in claim 1, wherein performing a procedure onthe mitral valve comprises attaching a clip to a first leaflet of themitral valve.
 20. A method of orienting a first and second tissuegrasper with respect to the mitral valve, comprising the steps of:providing a catheter having an elongate, flexible body, with a proximalend, a distal end and first and second tissue graspers spaced apart fromthe distal end; transluminally advancing the distal end from the leftatrium through the mitral valve and along the left ventricular outflowtract into the ascending aorta; engaging the left ventricular outflowtract or ascending aorta with the distal end; and positioning thecatheter by way of torqueing the proximal end relative to a fulcrumestablished by the step of engaging such that the first and secondtissue graspers are adjacent the mitral valve.
 21. The method as inclaim 20, further comprising the step of extending at least the firsttissue grasper radially outwardly from the flexible body.
 22. The methodas in claim 21, wherein the extending step comprises advancing the firsttissue grasper from a first position in which a longitudinal axis of thetissue grasper extends generally parallel with the flexible body, to asecond position in which the axis is inclined with respect to theflexible body.
 23. The method as in claim 21, wherein the extending stepcomprises advancing the first tissue grasper distally along a pathwaywhich is inclined with respect to a longitudinal axis of the catheter.24. The method of orienting a first and second tissue grasper withrespect to the mitral valve as in claim 20, further comprising attachinga clip to a first leaflet of the mitral valve.
 25. A method of graspinga mitral valve leaflet, comprising the steps of: providing a catheterhaving an elongate, flexible body, with a proximal end and a distal end;transluminally advancing the distal end from the left atrium through themitral valve and along the left ventricular outflow tract into theascending aorta; deploying a tissue grasper from a position on thecatheter spaced apart from the distal end; positioning the tissuegrasper by way of a fulcrum established at the distal end; and graspinga mitral valve leaflet by advancing the tissue grasper toward the valveleaflet from a position downstream of the valve leaflet to initiallygrasp the valve leaflet.
 26. The method of grasping a mitral valveleaflet as in claim 25, wherein the grasping step comprises piercing theleaflet.
 27. The method of grasping a mitral valve leaflet as in claim25, wherein the grasping step comprises trapping the leaflet.
 28. Themethod of grasping a mitral valve leaflet as in claim 25, wherein thegrasping step comprises applying suction to the leaflet.
 29. The methodof grasping a mitral valve leaflet as in claim 25, further comprisingattaching a clip to a first leaflet of the mitral valve.
 30. A method ofperforming an atrioventricular valve repair, comprising the steps of:providing a catheter having an elongate, flexible body, with a proximalend, a distal end, and a first and second leaflet grasper thereon, thefirst leaflet grasper being asymmetric to the second leaflet grasper;transluminally advancing the distal end from the left atrium through themitral valve and along the left ventricular outflow tract into theascending aorta such that a first lateral portion of the distal endbraces against a medial wall of the ascending aorta and a second lateralportion opposite the first lateral portion is spaced away from a lateralwall of the ascending aorta, such that a flow path is provided betweenthe second lateral portion and the lateral wall of the ascending aorta;positioning the first and second leaflet grasper relative to the mitralvalve by way of a fulcrum established at the first lateral portion ofthe distal end; grasping at least a first leaflet of the mitral valvewith the first leaflet grasper while maintaining blood flow ejected bythe heart through the flow path and around the distal end during abeating hear procedure; and securing the first leaflet to at least oneother anatomical structure while maintaining blood flow ejected by theheart through the flow path and around the distal end during a beatingheart procedure.
 31. The method of performing an atrioventricular valverepair as in claim 30, wherein the securing step comprises securing thefirst leaflet to a second leaflet.
 32. The method of performing anatrioventricular valve repair as in claim 30, wherein the securing stepcomprises securing the first leaflet to a valve annulus.
 33. The methodof performing an atrioventricular valve repair as in claim 30, whereinthe securing step comprises advancing a suture through the firstleaflet.
 34. The method of performing an atrioventricular valve repairas in claim 30, wherein the securing step comprises attaching a clip tothe first leaflet.
 35. The method of performing an atrioventricularvalve repair as in claim 30, wherein the securing step comprisesattaching a tissue anchor to the first leaflet.
 36. A method oforienting a catheter with respect to the mitral valve, comprising thesteps of: positioning a guidewire from the left atrium through themitral valve and along the left ventricular outflow tract into theascending aorta; advancing a catheter along the guidewire, the catheterhaving an anchor and a procedure site, the procedure site comprising aleaflet grasper spaced proximally apart from the anchor; and locatingthe anchor within the ascending aorta such that the leaflet grasper isat a predetermined orientation with respect to the mitral valve.
 37. Themethod of orienting a catheter as in claim 36, wherein the positioningstep includes the use of a flow directed structure.
 38. The method oforienting a catheter as in claim 36, wherein the locating the anchorstep comprises positioning a distal portion of the catheter within theascending aorta.
 39. The method of orienting a catheter as in claim 36,wherein the locating the anchor step comprises positioning the cathetersuch that it is approximately centered on the posterior leaflet of themitral valve.
 40. The method of orienting a catheter with respect to themitral valve as in claim 36, further comprising attaching a clip to afirst leaflet of the mitral valve.
 41. A method of performing aprocedure in the heart, comprising the steps of: providing a catheterhaving an elongate flexible body, a proximal end, a distal end, and aprocedure zone, spaced proximally apart from the distal end; advancingthe catheter through the right atrium, through the right ventricle andinto the pulmonary artery, such that the procedure zone is positioned ata treatment site, a length of the catheter extending proximally of thedistal end being positioned in the pulmonary artery to provide a fulcrumfor manipulating the procedure zone by torqueing the proximal end;performing a procedure on a tricuspid valve from the procedure zone;removing the catheter from the patient after performing the procedure;wherein the heart continues to beat from before the step of performingthe procedure until after the step of removing the catheter.
 42. Themethod of performing a procedure in the heart as in claim 41, whereinthe advancing step comprises advancing the catheter along a guidewire.43. The method of performing a procedure in the heart as in claim 42,wherein the procedure is performed on the tricuspid valve.
 44. Themethod of performing a procedure in the heart as in claim 42, whereinthe procedure is performed on the pulmonic valve.
 45. The method ofperforming a procedure in the heart as in claim 41, wherein theadvancing step comprises advancing the catheter to position the distalend in the right ventricle outflow tract of the pulmonary artery. 46.The method of performing a procedure in the heart as in claim 41,wherein the procedure comprises a valve repair.
 47. The method ofperforming a procedure in the heart as in claim 41, wherein theprocedure comprises grasping at least one leaflet of a valve.
 48. Themethod of performing a procedure in the heart as in claim 41, whereinthe procedure comprises attaching a first leaflet of a valve to a secondleaflet of a valve.
 49. The method of performing a procedure in theheart as in claim 41, wherein performing a procedure on a tricuspidvalve from the procedure zone comprises attaching a clip to a firstleaflet of the tricuspid valve.
 50. A method of performing a procedurein the heart, comprising the steps of: providing a catheter having anelongate flexible body, a proximal end, a distal end, and a procedurezone, the procedure zone comprising a leaflet grasper spaced proximallyapart from the distal end; advancing the catheter through at least twovalves in the heart, through a first chamber in the heart and at leastinto a second chamber in the heart; bracing the distal end of thecatheter against tissue disposed downstream of the at least two valvessuch that a first manipulation of the proximal end induces translationof the procedure zone along a line of coaptation of one of the at leasttwo valves and a second manipulation of the proximal end inducesrotation of the procedure zone relative to at least two leaflets of theone of the at least two valves; and performing a procedure on a heartvalve from the procedure zone.
 51. The method of performing a procedurein the heart as in claim 50, comprising advancing the catheter throughthe mitral valve and the aortic valve.
 52. The method of performing aprocedure in the heart as in claim 50, wherein the procedure comprises avalve repair.
 53. The method of performing a procedure in the heart asin claim 50, wherein performing a procedure on a heart valve from theprocedure zone comprises attaching a clip to a first leaflet of theheart valve.
 54. A method for repairing a heart valve, the methodcomprising: inserting a catheter proximal to first and second leafletsof a mitral valve, the catheter comprising an anchor zone spaceddistally apart from a first leaflet immobilization support; advancingthe anchor zone into the ascending aorta to bring the first leafletimmobilization support into the left ventricle; torqueing the anchoragainst an anatomical structure to position the first leafletimmobilization support over the first leaflet of the mitral valve;engaging the first leaflet of the mitral valve with the first leafletimmobilization support: engaging the second leaflet of the mitral valvewith a second leaflet immobilization support; advancing a first fixatingmember through the first leaflet immobilization support, engagingthereby a receptacle within the first leaflet immobilization support,wherein the receptacle is attached to a first end of fastening material;advancing a second fixating member through the second leafletimmobilization support, engaging thereby a receptacle within the secondleaflet immobilization support, wherein the receptacle is attached to asecond end of fastening material; retracting the fixating members,thereby pulling the fastening material through the leaflets; withdrawingthe catheter, the leaflet immobilization supports, and the fixatingmembers; and tying off the fastening material.
 55. The method of claim54, wherein the catheter further comprises an inflatable balloon, andthe method further comprises inflating the balloon during the step ofinserting the catheter proximal to the first and second leaflets of theheart valve.
 56. The method of claim 55, wherein the inflated balloonrests in the aortic valve anchoring the catheter.
 57. A method forrepairing a cardiac atrioventricular valve comprising: positioning aleaflet immobilization device across a mitral valve and an extensionthereof into the ventricular outflow tract wherein the ventricularoutflow tract and the extension orients the leaflet immobilizationdevice so that immobilization of the leaflets will occur withoutinterfering with papillary muscles, chordal structures, or other cardiacstructures, wherein a distal end of the extension braces against aportion of the ascending aorta to create a fulcrum that assists with thepositioning of the leaflet immobilization device.
 58. The method forrepairing a cardiac atrioventricular valve as in claim 57, furthercomprising attaching a clip to a first leaflet of the cardiacatrioventricular valve.